Definitions

For the purpose of this document, SGNA has adopted the following definitions:

Critical Medical Devices are those instruments that may be introduced directly into the bloodstream or into other normally sterile areas of the body (ASTM, 2000). These devices break the mucus membrane and/or come into contact with sterile tissue or the vascular system.

Reusable Device is an instrument designed and validated by the manufacturer to be used more than once, provided that after each use, an appropriate reprocessing protocol and functionality check is performed (ASTM, 2000).

Reuse refers to the repeated use or multiple use of any medical device including devices intended for reuse or single-use, with reprocessing (cleaning, disinfection or sterilization) between uses (FDA 2001).

Reprocessing refers to the sequence of cleaning, lubricating (if necessary), and sterilizing (ASTM, 2000) and high-level disinfection steps that will assure and endoscopic accessory is patient-ready.

Single Use Device, also referred to as a disposable device, is intended for one time use only, on one patient, during a single procedure. The manufacturer did not intend it to be reprocessed (cleaned, disinfected/sterilized) and/or used on another patient. The labeling may or may not identify the device as single use or disposable and does not include instructions for reprocessing (FDA, 2000).

Background

Cost-containment concerns have led healthcare facilities to consider reuse of single-use medical devices (SUDs). This statement is intended to address the controversy surrounding the issue of the reuse of critical medical devices manufactured and labeled for single-use.

Original equipment manufacturers (OEM) are required to conduct stringent testing processes for reusable products. The OEM must meet FDA criteria to validate that a device can be cleaned and, if necessary, re-sterilized in order for it to be labeled "reusable." These same stringent tests are not required for items intended for single use. Based on the results of these required tests, the original equipment manufacturers have defined recommended usage on package labels.

In August 2000, the FDA issued enforcement priorities for the regulation of third-party processors and hospitals that engage in reprocessing of SUDs (FDA, 2000). However, the FDA's enforcement priorities fail to include regulation of reprocessing that occurs in freestanding ambulatory surgery facilities or physician offices.

The reuse of SUDs is a complex issue that must be balanced with the assurance of patient safety and the delivery of quality healthcare. These concerns cannot be overlooked when evaluating the legal, ethical, financial and technical aspects of reusing SUDs. Furthermore, SGNA believes that patients deserve the same standard of care regardless of practice setting.

Position

The Society of Gastroenterology Nurses and Associates, Inc. maintains the position that critical medical devices originally manufactured and labeled for single use should not be reused. The OEM's recommendation regarding reuse of SUDs supersedes all other recommendations by any other entity.

References